Alzheimer's Disease dementia of the Alzheimer type
Conditions
Interventions
Intervention with a diagnostic medicine.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - age >45 - Written informed consent - Weight >50 kg , - Able to tolerate 70-minute scanning - No objective cognitive impairment (i.e. no diagnosis of dementia, mild cognitive impairment, psychiatric or neurological disorder explaining cognitive complaints). - MMSE >
Exclusion criteria
Exclusion criteria: Patients who 1. Have a current a major psychiatric disorder, such as psychosis, schizophrenia, severe personality disorder or depression with vital signs, abuse of alcohol or other substances. Or patients who have a neurological disorder, such as Parkinson's disease, symptomatic stroke, mental retardation. 2. Are women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Women of childbearing potential must not be pregnant (negative urine *-hCG at the time of screening and negative urine *-hCG on the day of imaging) or breast feeding at screening. Women must avoid becoming pregnant, and must agree to refrain from sexual activity or to use reliable contraceptive methods such as prescribed birth control or IUD for 24 hours following administration of florbetapir (18F); 3. Have a relevant history of severe drug allergy or hypersensitivity (relevant severe drug allergies should be determined by the Principal Investigator or Co-Principal Investigator, and any questions about a subject*s eligibility can be directed to Avid Radiopharmaceuticals Inc. If a subject has a history of severe drug allergies, it may be dangerous for them to participate in a study with a novel compound); 4. Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, *-secretase or *-secretase inhibitor) unless it can be documented that the subject received no investigational medication (yet) or only placebo during the course of the trial; 5. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The outcome measure, amyloid deposition (both visual and quantitative ), acquired with [18F]AV-45 PET scans in a memory clinic patient cohort. Quantification is performed with optimized kinetic models acquired in another research Florbetapir protocol (kinetic modelling of 18 F labeled amyloid tracers). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are the concordance of [18F]AV-45 PET with MRI markers (MTA) and with CSF markers (A* 1-42, total tau and p-tau 181) will be assessed by binary rating (e.g. *normal* or *abnormal*) and amyloid tracer quantification for each of these measures. Furthermore, at baseline dementia severity and neuropsychological measures will be obtained to allow analysis of associations with continuous measures of cognitive impairment to determine the prognostic value of [18F]AV-45 PET. | — |
Countries
Netherlands
Outcome results
None listed